Bioray Pharmaceutical Co. Ltd. has announced clinical trial clearance in China by the National Medical Products Administration (NMPA) for BR-111 for injection for the treatment of ROR1-positive hematological malignancies and solid tumors.
It’s one step backward in order to take two steps forward at Zentalis Pharmaceuticals Inc. In a restructuring to help fund the second part of its potentially registration-enabling Denali study, Zentalis has laid off 40% of its workforce. The clinical trial of azenosertib, Zentalis’ lead candidate and a WEE1 kinase inhibitor, is for treating advanced solid tumors and hematologic malignancies. The therapy is designed to make cancer cells self-destruct.
The U.S. FDA said it is investigating the risk of hematologic malignancies associated with Bluebird Bio Inc.’s Skysona (elivaldogene autotemcel), approved in 2022 as a one-time gene therapy for treating early active cerebral adrenoleukodystrophy in boys, ages 4 to 17.
Killer immunoglobulin-like receptor (KIR)-chimeric antigen receptor (CAR) T-cell therapies have previously demonstrated superior performance and functional persistence in solid tumor models, and the mesothelin-specific KIR-CAR T cells, Synkir-110, are now being evaluated in phase I trials by Verismo Therapeutics Inc.
Researchers from Sichuan Baili Pharmaceutical Co. Ltd. and Systimmune Inc. presented preclinical data for the novel CD33-targeting antibody-drug conjugate (ADC) being evaluated for the treatment of hematologic malignancies.
The transcription of ribosomal RNA by RNA Polymerase I (Pol I) is an essential step for cells to grow and thus is considered a therapeutic target for cancer treatment.
Presage Biosciences Inc. has announced that the FDA has issued a study may proceed notification for testing a pre-GMP drug candidate with the company’s Comparative In Vivo Oncology (CIVO) platform. Owned by Pure Biologics, the drug candidate, PBA-0405, is a ROR1-targeting compound that has been engineered to induce tumor cell killing by cytotoxic immune cells.